DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 30, 32-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gabriel et al (US 20190091412 A1).
Regarding claim 30, Gabriel discloses an electronic system (102, figs 5-6B) for a drug delivery device100, the electronic system comprising:
at least one user interface member (button 122) arranged to be manipulated by a user of the drug delivery device, wherein the user interface member 122 has a radially facing, circumferentially extending exterior operation surface 121 [0078-0079,0080-0081] arranged and configured to be touched by the user of the drug delivery device during operation of the drug delivery device;
wherein the user interface member 122 further comprises an axially oriented delivery surface (see fig 20, top surface of button 122) arranged to be contacted by the user for conducting a dose delivery operation ([0074-0075]; see also figures 19-20; [0130,0131]); and
an electrical user proximity detection unit (“proximity sensor”; there is a processor coupled to the rotary knob, the button, and others [0056]) configured to generate a signal via processor 128 when the user is close to or touches the radially facing, circumferentially extending exterior operation surface [0074, 0078, 0079];
the exterior operation surface 121 comprises a setting surface at 120 of the user interface member 122 which is arranged to be contacted for conducting or initiating a dose setting operation, and wherein the radially facing, circumferentially extending exterior operation surface is the setting surface [0078, 0080].
Regarding claim 32, Gabriel discloses the user proximity detection unit (“proximity sensor”) comprises an electrical sensor that is arranged and configured to detect whether the user is close to the exterior operation surface or touches the exterior operation surface, and wherein the sensor is a contactless or touchless proximity sensor, and/or wherein the user proximity detection unit comprises an electrical sensor that is arranged and configured to detect whether the user touches the exterior operation surface, and wherein the sensor is a contact sensor [0078-0079].
Regarding claim 33, Gabriel discloses the user proximity detection unit (“proximity sensor”) comprises a capacitive sensor that is arranged and configured to detect whether the user is close to or touches the exterior operation surface [0078].
Regarding claim 34, Gabriel discloses the user proximity detection unit (“proximity sensor”) comprises a sensor that comprises at least one electrically conductive contact surface accessible on the exterior operation surface, wherein the sensor is arranged and configured to detect whether the user touches the exterior operation surface 121 [0079-0080].
Regarding claim 35, Gabriel discloses the user proximity detection unit (“proximity sensor”) comprises a sensor that comprises multiple electrically conductive contact surfaces (touch screen, [0080] accessible on the exterior operation surface, wherein at least two electrically conductive contact surfaces of the multiple electrically conductive contact surfaces are arranged such that the user can simultaneously touch the at least two electrically conductive contact surfaces with one finger or two different fingers of a hand of the user, and wherein the at least two electrically conductive contact surfaces are configured to be surfaces having different electrical potentials, wherein the electronic system is configured such that the signal is formed by a current flowing through the hand of the user from one of the electrically conductive contact surfaces to another one of the electrically conductive contact surfaces when the user touches both contact surfaces simultaneously.
Regarding claim 36. Gabriel further discloses comprising an electronic control unit 128 (fig 6A-6B) configured to control an operation of the electronic system in response to the signal of the user proximity detection unit, wherein the electronic system has a first state and a second state, wherein the electronic system has a higher electrical power consumption in the second state as compared to the first state, wherein the electronic system further comprises an electrical use detection unit operatively connected to the electronic control unit, wherein the electrical use detection unit is configured to generate a use signal that indicates the user intends to perform a dose setting operation and/or a dose delivery operation, wherein the electronic system is configured to be switched from the first state into the second state in response to the use signal, wherein the use detection unit comprises the user proximity detection unit, and wherein the use signal is the signal generated by the user proximity detection unit when the user is close to or touches the exterior operation surface [0080- 0083].
Regarding claim 37, Gabriel discloses the electronic system comprises a motion sensing unit, wherein the motion sensing unit is configured to generate electrical motion signals suitable to quantify a relative movement of a first member relative to a second member, wherein the motion sensing unit is configured to be switched by the electronic control unit from a first state, in which the motion sensing unit is not operative, into a second state, in which the motion sensing unit is operative, in response to the use signal, and wherein the electronic system is configured such that the motion sensing unit operates during the dose delivery operation [ 0079-0081, 0100].
Regarding claim 38, Gabriel discloses the exterior operation surface 121 associated with generating the use signal is the setting surface, and the motion sensing unit is configured to monitor the dose delivery operation.
Regarding claim 39, Gabriel discloses the exterior operation surface 121 comprises a delivery surface at 106,122 arranged to be contacted for conducting or initiating a dose delivery operation, and wherein the exterior operation surface associated with generating the use signal is the delivery surface, and the motion sensing unit is configured to monitor the dose delivery operation [ 0079-0081, 0100].
Regarding claim 40, Gabriel discloses a wake-up unit [0079] configured to generate an electrical wake-up signal, wherein the electronic system is configured to switch the user proximity detection unit from a first state to a second state of higher power consumption in response to the wake-up signal, wherein the wake-up unit comprises an electrical wake-up sensor configured to generate the electrical wake-up signal [0079].
Regarding claim 41, Gabriel discloses wherein the electrical wake-up sensor is a vibration sensor [0079-0080].
Regarding claim 42, Gabriel discloses the electronic system is configured as a reusable add-on system for a disposable drug delivery device unit [0004, can be reusable or not].
Regarding claims 43-45, Gabriel discloses further comprising at least one sensor configured to be deactivated in response to the signal generated by the user proximity detection unit and the at least one sensor which is deactivated is the same sensor generating the signal of the user proximity detection unit in response to which it is deactivated; further comprising at least one sensor configured to have a response rate that changes in response to the signal generated by the user proximity detection unit, wherein the response rate of the at least one sensor or switch is increased or decreased in response to the signal generated by the user proximity detection unit ([0079-0080], wake-up of the touch screen implies a change in response rate i) a change of response rate (even if it is from non-respondent to respondent) and also ii) the presence of a deactivation sequence).
Regarding claim 46, Gabriel discloses further comprising at least one sensor configured to be deactivated or to change its response rate in response to the signal generated by the user proximity detection unit, and wherein the at least one sensor is different from a sensor that generates the signal of the proximity detection unit ([0079-0080], wake-up of the touch screen implies a change in response rate i) a change of response rate (even if it is from non-respondent to respondent) and also ii) the presence of a deactivation sequence).
Regarding claim 47, Gabriel discloses further comprising at least one sensor configured to change its response rate in response to the signal generated by the user proximity detection unit, wherein the user proximity detection unit comprises the at least one sensor, wherein the at least one sensor is the same as a sensor that generates the signal of the user proximity detection unit ([0079-0080], wake-up of the touch screen implies a change in response rate i) a change of response rate (even if it is from non-respondent to respondent) and also ii) the presence of a deactivation sequence).
Regarding claim 48, Gabriel discloses a drug delivery device 100 comprising:
an electronic system 102 that comprises at least one user interface member (button 122) arranged to be manipulated by a user of the drug delivery device, wherein the user interface member has a radially facing, circumferentially extending exterior operation surface 121 [0078-0079,0080-0081] and an axially oriented delivery surface arranged and configured to be touched by the user of the drug delivery device during operation of the drug delivery device; and
an electrical user proximity detection unit (proximity sensor; there is a processor 128 coupled to the rotary knob, the button, and others [0056]; fig 6b) configured to generate a signal when the user is close to or touches the radially facing, circumferentially extending exterior operation surface [0078,0079], wherein the drug delivery device comprises a reservoir with drug [0079], wherein the radially facing, circumferentially extending exterior operation surface 121 is a setting surface at 120 of the user interface member 122 which is arranged to be contacted by the user for conducting or initiating a dose setting operation [0078],
Regarding claim 49, Gabriel discloses the drug delivery device 100 is configured such that the device increases its length during a dose setting operation in an amount proportional to a size of a set dose (figs 11-16).
Response to Arguments
Applicant's arguments filed 06/08/2026 have been fully considered but they are not persuasive.
With respect to applicant’s arguments of pages 9-12, applicant is arguing more than what the structure and/or functional language of claims 30 and 48 states.
An analysis to claims 30 and 48 as argued on pages 9-12, claims 30 and 48 set forth “at least one user interface member arranged to be manipulated by a user of the drug delivery device, wherein the user interface member has a radially facing, circumferentially extending exterior operation surface arranged and configured to be touched by the user of the drug delivery device during operation of the drug delivery device”. The button 122 is considered as stated above is interpreted by the examiner to be the “at least one user an interface member” which is arranged and manipulated by a user according to Gabriel. Furthermore, Gabriel also discloses the user interface member having a radially facing, circumferentially extending exterior operation surface. Applicant is claiming a circular exterior surface at the end of the system to be touched by a user during operation, which is what Gabriel has in 121. “Radially facing…circumferentially…” means practically the same. Radial is from the center of a circumference, whereas an axial direction is along the longitudinal axis. Gabriel also meets these limitations as claimed.
With respect to claims 30 and 48, the language “wherein the user interface member further comprises an axially oriented delivery surface arranged to be contacted by the user for conducting a dose delivery operation”, the examiner interprets the user interface member 122 comprising an axially oriented delivery surface which is the top surface of button 122 since it is oriented toward the axis as seeing in figures 5, 6a, and 20. Therefore, Gabriel meets this limitation.
With respect to claims 30 and 48, the language “an electrical user proximity detection unit configured to generate a signal when the user is close to or touches the radially facing, circumferentially extending exterior operation surface, wherein the radially facing, circumferentially extending exterior operation surface is a setting surface of the user interface member, which is arranged to be contacted by the user for conducting or initiating a dose setting operation” has been interpreted as the processor 128 and proximity sensor described in [0078-0080] generating a signal when there is an object proximity. The radially facing, circumferentially extending exterior operation surface at top surface of button 122 is also a setting surface of the user interface member 122 [0078]. Therefore, Gabriel meets the claimed limitations.
The examiner recommends to further amend the claims in order to differentiate Gabriel from the invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights